Thorne

Purity-focused nutritional supplements with scientific rigor

Quality Assurance CAPA Specialist

Quality EngineeringUpdated on Nov 13

Full-timeSummerville, SC, USANo salary listedIn-person

About the Job

Requirements

A bachelor's degree in a scientific, engineering, or quality-related discipline, or an equivalent combination of education and experience.
At least 5 years of experience in a cGMP-regulated manufacturing environment with direct involvement in CAPA execution and quality systems.
Strong working knowledge of cGMP quality systems and structured root cause analysis.
Ability to effect change constructively and provide sound technical and supplier-related justification.
Ability to initiate and complete reports in a timely manner.

Responsibilities

Coordinate and govern the CAPA process in compliance with internal procedures, cGMP requirements, and regulatory expectations.
Serve as the CAPA subject matter expert and primary contact for process guidance, training, and continuous improvement.
Ensure CAPAs are initiated from deviations, investigations, audits, complaints, out-of-specification results, supplier issues, and external contract manufacturer quality events.
Facilitate CAPA meetings and reviews, ensuring actions are clearly defined, risk-based, and capable of preventing recurrence.
Review CAPA plans for technical adequacy, risk-based decision-making, clear ownership, and realistic timelines.
Lead and support structured root cause analysis using appropriate methodologies, and challenge inadequate investigations to identify deeper root causes when needed.
Verify CAPA effectiveness and ensure appropriate documentation and justification for closure.
Coordinate CAPA implementation, progress, and closure for outside contract manufacturers and external suppliers; support supply-chain governance by ensuring external CAPAs are timely, risk-based, and audit-defensible.
Build working relationships with Manufacturing, Quality Control, Engineering, Quality Assurance, Planning, Procurement, and external partners.
Compile and maintain CAPA metrics, dashboards, and periodic reports for management review.
Support internal audits, third-party audits, and regulatory inspections by providing CAPA documentation and serving as the CAPA subject matter expert.
Identify opportunities to improve CAPA workflows, templates, and tools.
Provide guidance and informal training to internal teams, outside contract manufacturers, and suppliers on CAPA best practices.
Stay current on regulatory expectations, industry trends, and best practices related to CAPA and quality systems.
Become thoroughly knowledgeable about applicable standard operating procedures and cGMPs and maintain that knowledge without relying on management direction.
Provide quality review and feedback on new products and processes as required.
Participate in process improvement teams to provide quality input and direction.
Ensure compliance with cGMP, FDA, OSHA, and other regulatory requirements.

Desired Qualifications

Experience supporting or overseeing CAPAs for outside contract manufacturers and/or suppliers.
Experience in project management or complex cross-functional initiatives.

At Thorne, we work to deliver high-quality, science-backed solutions to empower individuals to take a proactive approach to their well-being. Each day begins with a mission to help others discover and achieve their best health. We count on our team members to challenge and push the boundaries to make that happen. At Thorne, you’ll be joining a team of more than 750 passionate individuals committed to our cause of providing superior health solutions at every age and life stage.

The Quality Assurance (QA) CAPA Specialist is responsible and accountable for the execution, governance, and effectiveness of Thorne’s Corrective and Preventive Action (CAPA) program across internal manufacturing operations, Outside Contract Manufacturers (OCMs), and external suppliers.

This role serves as the CAPA subject matter expert and program coordinator within the Quality organization and is responsible for driving quality events to effective and sustainable resolution. The QA CAPA Specialist ensures CAPAs are initiated, investigated, implemented, tracked, and closed in a timely and compliant manner, and partners closely with Manufacturing, QC, Engineering, Supplier Qualification, Procurement, and external partners.

This role requires strong working knowledge of cGMP quality systems, structured root cause analysis, project management, and very strong communication skills to drive accountability across departments and external partners without direct authority.

Coordinates and governs Thorne’s CAPA process, ensuring compliance with internal procedures, cGMP requirements, and regulatory expectations.
Serves as the CAPA subject matter expert and primary contact for process guidance, training, and continuous improvement.Ensures CAPAs are appropriately initiated from deviations, investigations, audits, complaints, OOS, supplier issues, and OCM quality events.
Facilitates CAPA meetings and reviews, and ensures actions are clearly defined, risk-based, and capable of preventing recurrence.
Reviews CAPA plans for technical adequacy, risk-based decision-making, clear ownership, and realistic timelines.
Leads and supports structured root cause analysis using appropriate methodologies.
Challenges inadequate or superficial investigations and drive deeper root cause identification when needed.
Verifies CAPA effectiveness and ensures appropriate documentation and justification for closure.
Coordinates CAPA implementation, progress, and closure for Outside Contract Manufacturers (OCMs) and external suppliers. Supports supply chain governance by ensuring external CAPAs are timely, risk-based, and audit-defensible.
Builds strong working relationships with Manufacturing, QC, Engineering, QA, Planning, Procurement, and external partners.
Compiles and maintains CAPA metrics, dashboards, and periodic reports for management review.
Supports internal audits, third-party audits, and regulatory inspections by providing CAPA documentation and serving as CAPA SME.
Proactively identifies opportunities to improve CAPA workflows, templates, and tools.
Provides guidance and informal training to internal teams, OCMs, and suppliers on CAPA best practices.
Stays current on regulatory expectations, industry trends, and best practices related to CAPA and quality systems.
Becomes thoroughly knowledgeable of applicable SOPs and cGMPs and maintains knowledge without reliance on management direction.
Provides quality review and feedback on new products and processes as required.
Participates in process improvement teams to provide quality input and direction.
Ensures compliance with cGMP, FDA, OSHA, and all other regulatory requirements.

Bachelor’s degree required in a scientific, engineering, or quality-related discipline; or equivalent combination of education and experience.
5+ years of experience in a cGMP-regulated manufacturing environment with direct involvement in CAPA execution and quality systems.
Experience supporting or overseeing CAPAs for OCMs and/or suppliers strongly preferred.
Demonstrated experience in project management or complex cross-functional initiatives preferred.
Ability to effect change in a positive environment. Must be able to provide constructive arguments and sound justification as it pertains to technical and supplier requirements.
Initiates and completes reports in a timely manner

About the Company

Thorne

Purity-focused nutritional supplements with scientific rigor

Thorne is a health and wellness company that makes nutritional supplements. It focuses on purity and scientific backing, testing its products to ensure quality and efficacy for consumers. Its products work by delivering carefully studied nutrients and other ingredients in supplements that people take to support their health. Thorne differentiates itself from competitors through a long history dating back to 1984, a strong emphasis on quality and scientific integrity, and rigorous quality controls. In 2023 the company was acquired by L Catterton, moved off public markets, and continues to pursue growth by expanding research and development. The overall goal is to provide reliable, high-quality supplements that people can trust to support their health and well-being.

Company size: 501-1,000
Company stage: IPO
Headquarters: New York City, United States
Founded: 1984

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